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Abstract Background Research co-production is an umbrella term used to describe research users and researchers working together to generate knowledge. Research co-production is used to create knowledge that is relevant to current challenges and to increase uptake of that knowledge into practice, programs, products, and/or policy. Yet, rigorous theories and methods to assess the quality of co-production are limited. Here we describe a framework for assessing the quality of research co-production—Research Quality Plus for Co-Production (RQ+ 4 Co-Pro)—and outline our field test of this approach. Methods Using a co-production approach, we aim to field test the relevance and utility of the RQ+ 4 Co-Pro framework. To do so, we will recruit participants who have led research co-production projects from the international Integrated Knowledge Translation Research Network. We aim to sample 16 to 20 co-production project leads, assign these participants to dyadic groups (8 to 10 dyads), train each participant in the RQ+ 4 Co-Pro framework using deliberative workshops and oversee a simulation assessment exercise using RQ+ 4 Co-Pro within dyadic groups. To study this experience, we use a qualitative design to collect participant demographic information and project demographic information and will use in-depth semi-structured interviews to collect data related to the experience each participant has using the RQ+ 4 Co-Pro framework. Discussion This study will yield knowledge about a new way to assess research co-production. Specifically, it will address the relevance and utility of using RQ+ 4 Co-Pro, a framework that includes context as an inseparable component of research, identifies dimensions of quality matched to the aims of co-production, and applies a systematic and tra

BackgroundMost hospitals use physiological signs to trigger an urgent clinical review. We investigated whether facilitation could improve nurses’ vital sign measurement, interpretation, treatment and escalation of care for deteriorating patients.MethodsIn a pragmatic cluster randomised controlled trial, we randomised 36 inpatient wards at four acute hospitals to receive standard clinical practice guideline (CPG) dissemination to ward staff (n=18) or facilitated implementation for 6 months following standard dissemination (n=18). Expert, hospital and ward facilitators tailored facilitation techniques to promote nurses’ CPG adherence. Patient records were audited pre-intervention, 6 and 12 months post-intervention on randomly selected days. Escalation of care as per hospital policy was the primary outcome at 6 and 12 months after implementation. Patients, nurses and assessors were blinded to group assignment. Analysis was by intention-to-treat.ResultsFrom 10 383 audits, improved escalation as per hospital policy was evident in the intervention group at 6 months (OR 1.47, 95% CI (1.06 to 2.04)) with a complete set of vital sign measurements sustained at 12 months (OR 1.22, 95% CI (1.02 to 1.47)). There were no significant differences in escalation of care as per hospital policy between study groups at 6 or 12 months post-intervention. After adjusting for patient and hospital characteristics, a significant change from T0 in mean length of stay between groups at 12 months favoured the intervention group (−2.18 days, 95% CI (−3.53 to –0.82)).ConclusionMulti-level facilitation significantly improved escalation as per hospital policy at 6 months in the intervent

BACKGROUND: Context is recognized as important to successful knowledge translation (KT) in health settings. What is meant by context, however, is poorly understood. The purpose of the current study was to elicit tacit knowledge about what is perceived to constitute context by conducting interviews with a variety of health system stakeholders internationally so as to compile a comprehensive list of contextual attributes and their features relevant to KT in healthcare. METHODS: A descriptive qualitative study design was used. Semi-structured interviews were conducted with health system stakeholders (change agents/KT specialists and KT researchers) in four countries: Australia, Canada, the United Kingdom, and the United States. Interview transcripts were analyzed using inductive thematic content analysis in four steps: (1) selection of utterances describing context, (2) coding of features of context, (3) categorizing of features into attributes of context, (4) comparison of attributes and features by: country, KT experience, and role. RESULTS: A total of 39 interviews were conducted. We identified 66 unique features of context, categorized into 16 attributes. One attribute, Facility Characteristics, was not represented in previously published KT frameworks. We found instances of all 16 attributes in the interviews irrespective of country, level of experience with KT, and primary role (change agent/KT specialist vs. KT researcher), revealing robustness and transferability of the attributes identified. We also identified 30 new context features (across 13 of the 16 attributes). CONCLUSION: The findings from this study represent an important advancement in the KT field; we provide much needed conceptual clarity in context, which is essential to the development of common assessment tools to measure context to determine which context attributes and features are more or less important in different contexts for improving KT success.

BACKGROUND: Careful development of interventions using principles of co-production is now recognized as an important step for clinical trial development, but practical guidance on how to do this in practice is lacking. This paper aims (1) provide practical guidance for researchers to co-produce interventions ready for clinical trial by describing the 4-stage process we followed, the challenges experienced and practical tips for researchers wanting to co-produce an intervention for a clinical trial; (2) describe, as an exemplar, the development of our intervention package. METHOD: We used an Integrated Knowledge Translation (IKT) approach to co-produce a telehealth-delivered exercise program for people with stroke. The 4-stage process comprised of (1) a start-up planning phase with the co-production team. (2) Content development with knowledge user informants. (3) Design of an intervention protocol. (4) Protocol refinement. RESULTS AND REFLECTIONS: The four stages of intervention development involved an 11-member co-production team and 32 knowledge user informants. Challenges faced included balancing conflicting demands of different knowledge user informant groups, achieving shared power and collaborative decision making, and optimising knowledge user input. Components incorporated into the telehealth-delivered exercise program through working with knowledge user informants included: increased training for intervention therapists; increased options to tailor the intervention to participant's needs and preferences; and re-naming of the program. Key practical tips include ways to minimise the power differential between researchers and consumers, and ensure adequate preparation of the co-production team. CONCLUSION: Careful planning and a structured process can facilitate co-production of complex interventions ready for clinical trial.

BACKGROUND: Most hospitals use physiological signs to trigger an urgent clinical review. We investigated whether facilitation could improve nurses' vital sign measurement, interpretation, treatment and escalation of care for deteriorating patients. METHODS: In a pragmatic cluster randomised controlled trial, we randomised 36 inpatient wards at four acute hospitals to receive standard clinical practice guideline (CPG) dissemination to ward staff (n=18) or facilitated implementation for 6 months following standard dissemination (n=18). Expert, hospital and ward facilitators tailored facilitation techniques to promote nurses' CPG adherence. Patient records were audited pre-intervention, 6 and 12 months post-intervention on randomly selected days. Escalation of care as per hospital policy was the primary outcome at 6 and 12 months after implementation. Patients, nurses and assessors were blinded to group assignment. Analysis was by intention-to-treat. RESULTS: From 10 383 audits, improved escalation as per hospital policy was evident in the intervention group at 6 months (OR 1.47, 95% CI (1.06 to 2.04)) with a complete set of vital sign measurements sustained at 12 months (OR 1.22, 95% CI (1.02 to 1.47)). There were no significant differences in escalation of care as per hospital policy between study groups at 6 or 12 months post-intervention. After adjusting for patient and hospital characteristics, a significant change from T0 in mean length of stay between groups at 12 months favoured the intervention group (-2.18 days, 95% CI (-3.53 to -0.82)). CONCLUSION: Multi-level facilitation significantly improved escalation as per hospital policy at 6 months in the intervention group that was not sustained at 12 months. The intervention group had increased vital sign measurement by nurses, as well as shorter lengths of stay for patients at 12 months. Further research is required to understand the dose of facilitation required to impact clinical practice behaviours and patient

BACKGROUND: To increase the likelihood of successful implementation of evidence-based practices, researchers, knowledge users, and healthcare professionals must consider aspects of context that promote and hinder implementation in their setting. The purpose of the current study was to identify contextual attributes and their features relevant to implementation by healthcare professionals and compare and contrast these attributes and features across different clinical settings and healthcare professional roles. METHODS: We conducted a secondary analysis of 145 semi-structured interviews comprising 11 studies (10 from Canada and one from Australia) investigating healthcare professionals' perceived barriers and enablers to their use of research evidence in clinical practice. The data was collected using semi-structured interview guides informed by the Theoretical Domains Framework across different healthcare professional roles, settings, and practices. We analyzed these data inductively, using constant comparative analysis, to identify attributes of context and their features reported in the interviews. We compared these data by (1) setting (primary care, hospital-medical/surgical, hospital-emergency room, hospital-critical care) and (2) professional role (physicians and residents, nurses and organ donor coordinators). RESULTS: We identified 62 unique features of context, which we categorized under 14 broader attributes of context. The 14 attributes were resource access, work structure, patient characteristics, professional role, culture, facility characteristics, system features, healthcare professional characteristics, financial, collaboration, leadership, evaluation, regulatory or legislative standards, and societal influences. We found instances of the majority (n = 12, 86%) of attributes of context across multiple (n = 6 or more) clinical behaviors. We also found little variation in the 14 attributes of context by setting (primary care and hospitals) and professio

BACKGROUND: Health research is conducted with the expectation that it advances knowledge and eventually translates into improved health systems and population health. However, research findings are often caught in the know-do gap: they are not acted upon in a timely way or not applied at all. Integrated knowledge translation (IKT) is advanced as a way to increase the relevance, applicability and impact of research. With IKT, knowledge users work with researchers throughout the research process, starting with identification of the research question. Knowledge users represent those who would be able to use research results to inform their decisions (e.g. clinicians, managers, policy makers, patients/families and others). Stakeholders are increasingly interested in the idea that IKT generates greater and faster societal impact. Stakeholders are all those who are interested in the use of research results but may not necessarily use them for their own decision-making (e.g. governments, funders, researchers, health system managers and policy makers, patients and clinicians). Although IKT is broadly accepted, the actual research supporting it is limited and there is uncertainty about how best to conduct and support IKT. This paper presents a protocol for a programme of research testing the assumption that engaging the users of research in phases of its production leads to (a) greater appreciation of and capacity to use research; (b) the production of more relevant, useful and applicable research that results in greater impact; and (c) conditions under which it is more likely that research results will influence policy, managerial and clinical decision-making. METHODS: The research programme will adopt an interdisciplinary, international, cross-sector approach, using multiple and mixed methods to reflect the complex and social nature of research partnerships. We will use ongoing and future natural IKT experiments as multiple cases to study IKT in depth, and we will take adv

BACKGROUND: Vital signs are the primary indicator of physiological status and for determining the need for urgent clinical treatment. Yet, if physiological signs of deterioration are missed, misinterpreted or mismanaged, then critical illness, unplanned intensive care admissions, cardiac arrest and death may ensue. Although evidence demonstrates the benefit of early recognition and management of deteriorating patients, failure to escalate care and manage deteriorating patients remains a relatively frequent occurrence in hospitals. METHODS/DESIGN: A pragmatic cluster-randomised controlled trial design will be used to measure clinical effectiveness and cost of a facilitation intervention to improve nurses' vital sign measurement, interpretation, treatment and escalation of care for patients with abnormal vital signs. A cost consequence analysis will evaluate the intervention cost and effectiveness, and a process evaluation will determine how the implementation of the intervention contributes to outcomes. We will compare clinical outcomes and costs from standard implementation of clinical practice guidelines (CPGs) to facilitated implementation of CPGs. The primary outcome will be adherence to the CPGs by nurses, as measured by escalation of care as per organisational policy. The study will be conducted in four Australian major metropolitan teaching hospitals. In each hospital, eight to ten wards will be randomly allocated to intervention and control groups. Control wards will receive standard implementation of CPGs, while intervention wards will receive standard CPG implementation plus facilitation, using facilitation methods and processes tailored to the ward context. The intervention will be administered to all nursing staff at the ward level for 6 months. At each hospital, two types of facilitators will be provided: a hospital-level facilitator as the lead; and two ward-level facilitators for each ward. DISCUSSION: This study uses an innovative, networked approach

Evidence indicates that many barriers exist to the integration of genetic case finding into primary care. We conducted an exploratory study of the determinants of three specific behaviours related to using breast cancer genetics referral guidelines effectively: 'taking a family history', 'making a risk assessment', and 'making a referral decision'. We developed vignettes of primary care consultations with hypothetical patients, representing a wide range of genetic risk for which different referral decisions would be appropriate. We used the Theory of Planned Behavior to develop a survey instrument to capture data on behavioural intention and its predictors (attitude, subjective norm, and perceived behavioural control) for each of the three behaviours and mailed it to a sample of Canadian family physicians. We used correlation and regression analyses to explore the relationships between predictor and dependent variables. The response rate was 96/125 (77%). The predictor variables explained 38-83% of the variance in intention across the three behaviours. Family physicians' intentions were lower for 'making a risk assessment' (perceived as the most difficult) than for the other two behaviours. We illustrate how understanding psychological factors salient to behaviour can be used to tailor professional educational interventions; for example, considering the approach of behavioural rehearsal to improve confidence in skills (perceived behavioural control), or vicarious reinforcement as where participants are sceptical that genetics is consistent with their role (subjective norm).

BACKGROUND: Pragmatic trials of implementation interventions focus on evaluating whether an intervention changes professional behaviour under real-world conditions rather than investigating the mechanism through which change occurs. Theory-based process evaluations conducted alongside pragmatic randomised trials address this by assessing whether the intervention changes theoretical constructs proposed to mediate change. The Ontario Printed Educational Materials (PEM) cluster trial was designed to increase family physicians' guideline-recommended prescription of thiazide diuretics. The trial found no intervention effect. Using the theory of planned behaviour (TPB), we hypothesised that changes in thiazide prescribing would be reflected in changes in intention, consistent with changes in attitude and subjective norm, with no change to their perceived behavioural control (PBC), and tested this alongside the RCT. METHODS: We developed and sent TPB postal questionnaires to a random sub-sample of family physicians in each trial arm 2 months before and 6 months after dissemination of the PEMs. We used analysis of covariance to test for group differences using a 2 × 3 factorial design. We content-analysed an open-ended question about perceived barriers to thiazide prescription. Using control group data, we tested whether baseline measures of TPB constructs predicted self-reported thiazide prescribing at follow-up. RESULTS: Four hundred twenty-six physicians completed pre- and post-intervention questionnaires. Baseline scores on measures of TPB constructs were high: intention mean = 5.9 out of 7 (SD = 1.4), attitude mean = 5.8 (SD = 1.1), subjective norm mean = 5.8 (SD = 1.1) and PBC mean = 6.2 (SD = 1.0). The arms did not significantly differ post-intervention on any of the theory-based constructs, suggesting a possible ceiling effect. Content analysis of perceived barriers suggested post-intentional barriers to prescribing thiazides most often focused on specific patient c

BACKGROUND: There is growing recognition that "context" can and does modify the effects of implementation interventions aimed at increasing healthcare professionals' use of research evidence in clinical practice. However, conceptual clarity about what exactly comprises "context" is lacking. The purpose of this research program is to develop, refine, and validate a framework that identifies the key domains of context (and their features) that can facilitate or hinder (1) healthcare professionals' use of evidence in clinical practice and (2) the effectiveness of implementation interventions. METHODS/DESIGN: A multi-phased investigation of context using mixed methods will be conducted. The first phase is a concept analysis of context using the Walker and Avant method to distinguish between the defining and irrelevant attributes of context. This phase will result in a preliminary framework for context that identifies its important domains and their features according to the published literature. The second phase is a secondary analysis of qualitative data from 13 studies of interviews with 312 healthcare professionals on the perceived barriers and enablers to their application of research evidence in clinical practice. These data will be analyzed inductively using constant comparative analysis. For the third phase, we will conduct semi-structured interviews with key health system stakeholders and change agents to elicit their knowledge and beliefs about the contextual features that influence the effectiveness of implementation interventions and healthcare professionals' use of evidence in clinical practice. Results from all three phases will be synthesized using a triangulation protocol to refine the context framework drawn from the concept analysis. The framework will then be assessed for content validity using an iterative Delphi approach with international experts (researchers and health system stakeholders/change agents). DISCUSSION: This research program will resul

BACKGROUND: Theory-based process evaluations conducted alongside randomized controlled trials provide the opportunity to investigate hypothesized mechanisms of action of interventions, helping to build a cumulative knowledge base and to inform the interpretation of individual trial outcomes. Our objective was to identify the underlying causal mechanisms in a cluster randomized trial of the effectiveness of printed educational materials (PEMs) to increase referral for diabetic retinopathy screening. We hypothesized that the PEMs would increase physicians' intention to refer patients for retinal screening by strengthening their attitude and subjective norm, but not their perceived behavioral control. METHODS: Design: A theory based process evaluation alongside the Ontario Printed Educational Material (OPEM) cluster randomized trial. Postal surveys based on the Theory of Planned Behavior were sent to a random sample of trial participants two months before and six months after they received the intervention. Setting: Family physicians in Ontario, Canada. Participants: 1,512 family physicians (252 per intervention group) from the OPEM trial were invited to participate, and 31.3% (473/1512) responded at time one and time two. The final sample comprised 437 family physicians fully completing questionnaires at both time points. Main Outcome Measures: Primary: behavioral intention related to referring patient for retinopathy screening; secondary: attitude, subjective norm, perceived behavioral control. RESULTS: At baseline, family physicians reported positive intention, attitude, subjective norm, and perceived behavioral control to advise patients about retinopathy screening suggesting limited opportunities for improvement in these constructs. There were no significant differences on intention, attitude, subjective norm, and perceived behavioral control following the intervention. Respondents also reported additional physician- and patient-related factors perceived to influe

BACKGROUND: Randomised controlled trials of implementation strategies tell us whether (or not) an intervention results in changes in professional behaviour but little about the causal mechanisms that produce any change. Theory-based process evaluations collect data on theoretical constructs alongside randomised trials to explore possible causal mechanisms and effect modifiers. This is similar to measuring intermediate endpoints in clinical trials to further understand the biological basis of any observed effects (for example, measuring lipid profiles alongside trials of lipid lowering drugs where the primary endpoint could be reduction in vascular related deaths).This study protocol describes a theory-based process evaluation alongside the Ontario Printed Educational Message (OPEM) trial. We hypothesize that the OPEM interventions are most likely to operate through changes in physicians' behavioural intentions due to improved attitudes or subjective norms with little or no change in perceived behavioural control. We will test this hypothesis using a well-validated social cognition model, the theory of planned behaviour (TPB) that incorporates these constructs. METHODS/DESIGN: We will develop theory-based surveys using standard methods based upon the TPB for the second and third replications, and survey a subsample of Ontario family physicians from each arm of the trial two months before and six months after the dissemination of the index edition of informed, the evidence based newsletter used for the interventions. In the third replication, our study will converge with the "TRY-ME" protocol (a second study conducted alongside the OPEM trial), in which the content of educational messages was constructed using both standard methods and methods informed by psychological theory. We will modify Dillman's total design method to maximise response rates. Preliminary analyses will initially assess the internal reliability of the measures and use regression to explore the rel